Newark, United States
5 months ago
This position can be located in Tarrytown, NY or Newark, DE. Manager looking for 2-5 years experience
Duties Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:
- Regulatory review of technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).
- Gather regulatory documents and information to support creation of technical documentation.
- Identify and close gaps in technical documentation.
- Work collaboratively to complete tasks, both within regulatory affairs and with other departments.
- Create, review, and route for approval EU Declarations of Conformity.
- Provide periodic progress reports to supervisors.
- Attend in-person and teleconference meetings as assigned.
- Prepare finished IVDR technical documentation for submission to the Notified Body.
- Prepare quality records for electronic archival.
- Education: Bachelor of Art/Science in a Science related field.
- Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.
- Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel).
- Great time management and organizational skills.
- Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) and/or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).
- Experience with SAP.
- Experience with medical device labeling review.
- Regulatory Affairs experience with in vitro diagnostics.
- Proficiency with Windows 10 and Microsoft Office 365.
Work location can be Newrak, DE or Tarrytown, NY